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Anti-tumor antibiotic

Chemoperfusion for Mesothelioma

Phase 2

Waitlist Available

Led By Bela Kis, M.D., Ph.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%)

The predominant burden of disease lies in an arterial distribution which is accessible for transarterial chemoperfusion treatment

Must not have

Uncontrolled intercurrent illness including, but not limited to, presence of other malignancy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Recovery means resolution to at least Grade 1 toxicity if there was no baseline toxicity or less than or equal to the patient's baseline value

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new chemo treatment for adults with a specific type of cancer.

Who is the study for?

Adults with malignant pleural mesothelioma (MPM) that's not removable by surgery or those who refuse surgery. They must have tried and not responded to standard chemotherapy, or refused it. Participants need to be in good enough health for the treatment, not pregnant or breastfeeding, willing to use contraception, and able to follow study procedures.

What is being tested?

The trial is testing a procedure called transarterial chemoperfusion using drugs cisplatin, methotrexate, and gemcitabine. It aims to find out if this method is safe and effective for treating MPM when delivered directly into arteries feeding the tumor.

What are the potential side effects?

Possible side effects include reactions related to cisplatin, methotrexate, and gemcitabine such as nausea, vomiting, kidney problems, mouth sores from methotrexate; low blood counts can also occur increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities by myself without help.

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My main cancer area can be reached for treatment through an artery.

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My mesothelioma cannot be removed by surgery or I choose not to have surgery.

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My cancer, mesothelioma, has been confirmed by lab tests.

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My cancer did not improve after first chemotherapy or I refused it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I haven't had chemotherapy in the last 4 weeks or I've recovered from its side effects.

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I am HIV-positive and on combination anti-retroviral therapy.

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I have cancer that has spread to my brain or the lining around my brain.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease Control Rate (DCR)

Secondary study objectives

Occurrence of Treatment Related Toxicity

Overall Survival (OS)

Progression Free Survival (PFS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemoperfusion + QuestionnaireExperimental Treatment4 Interventions

Transarterial Chemoperfusion treatment with cisplatin (35 mg/m\^2), methotrexate (100 mg/m\^2) and gemcitabine (1000 mg/m\^2). Patients undergo angiogram and transarterial chemoperfusion treatment in every 4 weeks (3-6 weeks interval allowed) when cisplatin, methotrexate and gemcitabine will be administered into the thoracic aorta and/or the internal mammary artery on the side of the disease. Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Methotrexate

2019

Completed Phase 4

~4400